Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscle Hypotonia
- Sponsor
- Universidad de Murcia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.
Detailed Description
Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.
Investigators
María Guadalupe de Santos Moreno
Principal Investigator
Universidad de Murcia
Eligibility Criteria
Inclusion Criteria
- •Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old
Exclusion Criteria
- •Other hypotonic syndromes
Outcomes
Primary Outcomes
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
Time Frame: 1 month
A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.
Analysis of the reliability of the scale
Time Frame: 1 month
Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed
Content validity
Time Frame: 1 month
It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Empirical validity.
Time Frame: 1 month
The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Structural validity
Time Frame: In the process of analysis. 1 month to get results.
Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.
Secondary Outcomes
- Descriptive analysis of the scale(1 month)
- Analysis of the scale items.(1 month)
- Frequency analysis of the items.(1 month)